Abstract
Background:
A series of studies has suggested some efficacy of glucosamine in arthrosis of the knee, but virtually no documentation exists regarding its effects on low back pain.
Objectives:
The primary objective of this study was to examine whether a 12-week course of a glucosamine complex (GC) could benefit patients having low back pain despite a course of noninvasive physical therapy. In addition, we sought to delineate the subgroup of responders.
Methods:
This open-label, randomized, controlled study was conducted at the Division of Rheumatology and Physical Medicine, Erasme University Hospital, Brussels, Belgium. Male and female outpatients aged 40 to 80 years with low back pain (duration, ≥ 12 weeks; pain score on 10-cm visual analog scale [VAS] [0 = none to 10 = worst imaginable], ≥3 cm) despite noninvasive physical therapy (massage, stretching, heat application, and analgesics for ≥4 weeks) were included. Patients were randomly assigned to receive, in addition to conventional treatment (CT) (physical therapy plus analgesics/antiinflammatories), a GC (enriched with sulfonyl methane, silicon, and a botanical extract of Ribes nigrum) or CT alone (control) for 12 weeks. Pain at rest and on movement (effort) and early morning lumbar stiffness were measured every 4 weeks using the VAS. The primary end point was improvement in VAS score for pain at rest at 12 weeks. Two validated questionnaires were used to assess improvements in quality of life (QOL) (Oswestry Disability Questionnaire [ODQ] [10 items; scale: 0 = no disability to 60 = maximal disability] and Roland-Morris Disability Questionnaire [RMDQ] [24 items; scale: 0 = no disability to 24 = severe disability]). Responders were defined as patients who positively assessed the efficacy of the GC. At each visit, patients were also asked about possible adverse events.
Results:
Of 36 enrolled patients, 32 completed the study (18 men, 14 women; mean [SE] age, 64 [2] years; 17 in the GC group and 15 in the control group). Four patients were lost to follow-up. At week 4, changes from baseline VAS scores for pain at rest and lumbar stiffness were significantly greater in the GC group compared with the control group (P < 0.001 and P = 0.011, respectively). At week 4, QOL was found to be improved, as measured using the ODQ, in the GC group compared with the control group (P = 0.028), but the between-group difference as measured using the RMDQ was not significant. The improvements from baseline on the questionnaires were sustained over the 12-week period in the GC group (all, P < 0.001). Gastrointestinal adverse effects were reported by 1 GC-treated patient and 1 patient in the control group, but neither patient withdrew from the study. Of the 17 GC-treated patients, 9 considered themselves responders, but the profile of a responder could not be delineated.
Conclusions:
In this study in patients with low back pain, analgesic effect and improvement in QOL were found with the use of GC. GC was well tolerated.
Key words: arthrosis, back pain, glucosamine, methylsulfonylmethane, silicon, Ribes nigrurn
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References
- 1.Houpt J.B., McMillan R., Wein C., Paget-Dellio S.D. Effect of glucosamine hydrochloride in the treatment of pain of osteoarthritis of the knee. J Rheumatol. 1999;26:2423–2430. [PubMed] [Google Scholar]
- 2.Lozada C., Altman R. Management of limb joint osteoarthritis. In: Harris E.D. Jr, Kelley W.N., editors. Kelley's Textbook of Rheumatology. 7th ed. Elsevier Saunders; Philadelphia, Pa: 2005. pp. 1856–1861. [Google Scholar]
- 3.Bruyere O., Pavelka K., Rovati L.C. Glucosamine sulfate reduces osteoarthritis progression in postmenopausal women with knee osteoarthritis: Evidence from two 3-year studies. Menopause. 2004;11:138–144. doi: 10.1097/01.gme.0000087983.28957.5d. [DOI] [PubMed] [Google Scholar]
- 4.Poolsup N., Suthisisang C., Channark P., Kittikulsuth W. Glucosamine long-term treatment and the progression of knee osteoarthritis: Systematic review of randomized controlled trials. Ann Pharmacother. 2005;39:1080–1087. doi: 10.1345/aph.1E576. [DOI] [PubMed] [Google Scholar]
- 5.Borenstein D. Low back pain and lumbar spinal stenosis. In: Hochberg M.C., Silman A., Smolen J., editors. Rheumatology. 3rd ed. Mosby; St. Louis, Mo: 2003. pp. 583–613. [Google Scholar]
- 6.van Tulder M.W., Scholten R.J., Koes B.W., Deyo R.A. Nonsteroidal anti-inflammatory drugs for low back pain: A systematic review within the framework of the Cochrane Collaboration Back Review Group. Spine. 2000;25:2501–2513. doi: 10.1097/00007632-200010010-00013. [DOI] [PubMed] [Google Scholar]
- 7.Sarzi-Puttini P., Cimmino M.A., Scarpa R. Osteoarthritis: An overview of the disease and its treatment strategies. Semin Arthritis Rheum. 2005;35(Suppl 1):1–10. doi: 10.1016/j.semarthrit.2005.01.013. [DOI] [PubMed] [Google Scholar]
- 8.Berman B., Gournelos E., Lewith G. Complementary and alternative medicine. In: Hochberg M.C., Silman A., Smolen J., editors. Rheumatology. 3rd ed. Mosby; St. Louis, Mo: 2003. pp. 505–516. [Google Scholar]
- 9.Anderson J.W., Nicolosi R.J., Borzelleca J.F. Glucosamine effects in humans: A review of effects on glucose metabolism, side effects, safety considerations and efficacy. Food Chem Toxicol. 2005;43:187–201. doi: 10.1016/j.fct.2004.11.006. [DOI] [PubMed] [Google Scholar]
- 10.Dobson G. Leaf lipids of Robes nigrum: A plant containing 16:3, alpha-18:3, gamma-18:3 and 18:4 fatty acids. Biochem Soc Trans. 2000;28:583–586. [PubMed] [Google Scholar]
- 11.Garbacki N., Angenot L., Bassleer C. Effects of prodelphinidins isolated from Robes nigrum on chondrocyte metabolism and COX activity. Naunyn Schmiedebergs Arch Pharmacol. 2002;365:434–441. doi: 10.1007/s00210-002-0553-y. [DOI] [PubMed] [Google Scholar]
- 12.Lawrence R.M. Methylsulfonylmethane: A double blind study of its use in degenerative arthritis. Int J Antiaging Med. 1998;1:50. [Google Scholar]
- 13.Moh J.H., Choi Y.H., Lim K.M. A prodrug approach to COX-2 inhibitors with methylsulfone. Bioorg Med Chem Lett. 2004;14:1757–1760. doi: 10.1016/j.bmcl.2004.01.048. [DOI] [PubMed] [Google Scholar]
- 14.Parcell S. Sulfur in human nutrition and applications in medicine. Altern Med Rev. 2002;7:22–44. [PubMed] [Google Scholar]
- 15.Schiano A., Eisinger F., Detolle P. Silicon, bone tissue and immunity [in French] Rev Rhum Mal Osteoartic. 1979;46:483–486. [PubMed] [Google Scholar]
- 16.Pocock S.J. Clinical Trials: A Practical Approach. Wiley; New York, NY: 1983. [Google Scholar]
- 17.Atromal (glucosamine complex) [product information] Laboratories Dolisos SA; Toulouse, France: 2005. [Google Scholar]
- 18.Bradley L.A. Pain measurement in arthritis. Arthritis Care Res. 1993;6:178–186. doi: 10.1002/art.1790060404. [DOI] [PubMed] [Google Scholar]
- 19.Stratford P.W., Binkley J., Solomon P. Defining the minimum level of detectable change for the Roland-Morris questionnaire. Phys Ther. 1996;76:359–365. doi: 10.1093/ptj/76.4.359. [DOI] [PubMed] [Google Scholar]
- 20.Fairbank J.C., Couper J., Davies J.B., O'Brien J.P. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980;66:271–273. [PubMed] [Google Scholar]
- 21.Ward M. Assessment of health outcomes. In: Harris E.D. Jr, Kelley W.N., editors. Kelley's Textbook of Rheumatology. 7th ed. Elsevier Saunders; Philadelphia, Pa: 2005. pp. 435–446. [Google Scholar]
- 22.Winer B.J. Statistical Principles in Experimental Design. 3rd ed. McGraw-Hill; New York, NY: 1991. [Google Scholar]
- 23.Datta D., Mirza S.K., White A. Low back pain. In: Harris E.D. Jr, Kelley W.N., editors. Kelley's Textbook of Rheumatology. 7th ed. Elsevier Saunders; Philadelphia, Pa: 2005. pp. 588–600. [Google Scholar]